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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: PACTR
Last refreshed on: 29 April 2013
Main ID:  PACTR201011000264179
Date of registration: 17/11/2010
Primary sponsor: Linzette Morris
Public title: Virtual reality exposure therapy and fibromyalgia
Scientific title: Virtual reality exposure therapy therapy as treatment for pain catastrophizing in fibromylagia patients: Proof-of-concept
Date of first enrolment: 2011-02-07
Target sample size: 20
Recruitment status: Not yet recruiting
URL:  HTTP://www.pactr.org/ATMWeb/appmanager/atm/atmregistry?da=true&tno=PACTR201011000264179
Study type:  interventional
Study design:  Parallel: different groups receive different interventions at same time during study,
Randomised,
Statistician will build a computer-generated random numbers table will be used to allocate subjects to groups. ,
Allocation will be concealed by placing group identification in sealed opaque envelopes,
 
Countries of recruitment
South Africa
Contacts
Name: Linzette  Morris
Address:  140 Spencer Street 7460 Goodwood South Africa
Telephone: +27 21 5925132
Email: ldmorris@sun.ac.za
Affiliation:  Researcher/Stellenbosch University
Name: Linzette  Morris
Address:  140 Spencer Street 7460 Goodwood South Africa
Telephone: +27 215925132
Email: ldmorris@sun.ac.za
Affiliation:  Researcher/Stellenbosch University
Key inclusion & exclusion criteria
Inclusion criteria: Adult male and female subjects
Between ages of 18 and 65 years old
clinically diagnosed with FMS according to the American College Rheumatology (ACR) criteria [26] by a qualified rheumatologist subjectively report high PCS (more than 24 points) and TSK (more than 37 points) scores
able to speak, read English, Afrikaans and Xhosa

Exclusion criteria: diagnosed with other conditions not related to FMS i.e. cancer;
severe physical disabilities;
suffer from other chronic conditions i.e. systemic lupus erythmatosus, rheumatoid arthritis, etc;
previously been hospitalized for a major psychiatric disorder;
uncontrolled endocrine or allergic disorder; using medication other than the prescribed pharmacologic agents for FMS symptoms;
using any narcotics long-term;
currently or who have previously abused any illicit substances or alcohol;
diagnosed with epilepsy, or other conditions contraindicated in the use of visual exposures to stimuli;
contraindications which prohibit the use of fMRI, i.e. cardiac pacemakers, metal implants, claustrophobia, pregnancy and cochlear implants;
unable to discontinue intake of anti-depressants 4 weeks prior to commencement of study


Age minimum: 18 Year
Age maximum: 65 Year
Gender: Both
Health Condition(s) or Problem(s) studied

Fibromyalgia
Intervention(s)
Primary Outcome(s)
pain catastrophizing
Secondary Outcome(s)
Kinesiophobia
Secondary ID(s)
N10/05/184
Source(s) of Monetary Support
National Research Fund
Harry Crossley Foundation
Stellenbosch University Postgraduate merit award
Secondary Sponsor(s)
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